BILL ANALYSIS �
SB 1014
Page 1
Date of Hearing: June 17, 2014
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Luis Alejo, Chair
SB 1014 (Jackson) - As Amended: June 10, 2014
SENATE VOTE : 33-3
SUBJECT : Pharmaceutical waste: home generated: collection.
SUMMARY : Requires the Department of Resources Recycling and
Recovery (CalRecycle) and the California State Board of Pharmacy
to jointly develop regulations authorizing a voluntary program
to collect and properly dispose of home-generated pharmaceutical
waste (HGPW). Specifically, this bill :
1)Authorizes a pharmacy to accept the return of HGPW from a
consumer, consistent with the Federal Food, Drug, and Cosmetic
Act and the federal Controlled Substances Act.
2)Defines HGPW as a prescription or over-the-counter human or
veterinary home-generated pharmaceutical, including a drug
that is a waste, derived from a household, including a
multifamily residence or household.
3)Specifies that HGPW, including consolidated HGPW that is
handled by a collection and disposal program operating in
accordance with the regulations adopted by CalRecycle is not
medical waste.
4)Defines terms, including:
a) "Consumer" as an individual purchaser or owner of a
pharmaceutical. Specifies that "consumer" does not include
a business, corporation, limited partnership, or an entity
involved in a wholesale transaction between a distributor
and retailer;
b) "Entity" as a state or local public agency, pharmacy,
veterinarian clinic, or other office or facility; and,
c) "Participant" as an entity that CalRecycle deems
appropriate for implementing and evaluating a program in
accordance with the HGPW regulations and that chooses to
participate.
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5)Requires, by January 1, 2016, CalRecycle and the California
State Board of Pharmacy to jointly develop regulations, to be
approved by both agencies before adoption, authorizing a
participant to establish a program to collect and properly
dispose of HGPW. Requires the regulations to be based upon
the model guidelines developed by CalRecycle and to require a
participant to do the following:
a) Provide, at no additional cost to the consumer, for the
safe take back and proper disposal of pharmaceuticals;
b) Ensure the protection of the public health and safety,
the environment, and the health and safety of consumers and
employees;
c) Report to CalRecycle for purposes of evaluation the
safety, efficiency, and effectiveness of the implemented
program on an annual basis;
d) Protect against the potential for the diversion of
pharmaceutical waste for unlawful use or sale; and,
e) Provide notices and materials, as specified, to
consumers that provide information about the potential
impacts of improper disposal of HGPW and the return
opportunities for the proper disposal of HGPW.
6)Requires the HGPW regulations to do all of the following:
a) Specify the types of participants authorized to maintain
permanent collection locations;
b) Specify any requirements for obtaining state permits or
approvals;
c) Require participants to enter into arrangements with
medical or hazardous waste haulers, including ensuring that
all HGPW is appropriately picked up and transported by
registered waste haulers;
d) Specify which HGPW may be included in a program,
including requirements for the collection of a controlled
substance;
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e) Specify methods for handling wastes commingled in
containers with other household waste or hazardous waste;
f) Provide methods for collecting and storing HGPW,
including the use of secured containers, and ensure that
collected HGPW is not resold, reused, sold, donated, or
provided to anyone other than a registered medical or
hazardous waste hauler;
g) Provide that a facility that collects HGPW is
responsible for ensuring that the storage, removal, and
transportation of containers and the disposal of the waste
are in compliance with state laws and regulations;
h) Require the collection and retention of detailed
information and invoices for each collection site;
i) Impose requirements for one-time or periodic collection
events and for mail-back collection and disposal programs;
and,
7)Requires CalRecycle to include in the regulations provisions
for the appropriate management of consolidated HGPW to ensure
the public health and safety.
8)Deems a participant operating a program in accordance with the
HGPW regulations to be in compliance with all state laws and
regulations concerning the handling, management, and disposal
of HGPW.
EXISTING LAW :
Requires, under the federal Controlled Substances Act, protocols
for the collection of controlled substances to prevent their
illegal diversion and abuse. (21 U.S.C. Sec. 801 et seq.)
Establishes the Federal Food, Drug, and Cosmetic Law,
administered by the Department of Public Health (DPH), to
regulate drugs and medical devices. (21 U.S.C. Sec. 301 et
seq.)
Pursuant to the Business and Professions Code (BPC):
1) Establishes the Pharmacy Law, which provides for the
licensure and regulation of pharmacies, pharmacists, and
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wholesalers of dangerous drugs or devices by the Board of
Pharmacy within the Department of Consumer Affairs. (BPC �
4000 et seq.)
2) Authorizes a pharmacy to accept the return of needles and
syringes from the public if contained in a sharps container.
(BPC � 4146)
Pursuant to the Health and Safety Code (HSC):
1) Establishes the California Uniform Controlled Substances Act,
which regulates controlled substances. (HSC � 11000 et seq.)
2) Defines a drug as substances recognized as drugs in the
official United States Pharmacopoeia, official Homeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them; substances
intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or animals; and,
substances (other than food) intended to affect the structure
or any function of the body of man or animals. (HSC � 11014)
3) Establishes the Medical Waste Management Act (MWMA) which
regulates the generation, handling, storage, transport,
treatment, and disposal of medical waste, as defined, and is
overseen by DPH and designated local agencies. (HSC �117600
et seq.)
4) Defines "household waste" as any material, including garbage,
trash, and sanitary wastes in septic tanks and medical waste
that is derived from households, farms, or ranches. (HSC �
117670)
5) Defines "pharmaceuticals" as a prescription or
over-the-counter human or veterinary drug including, but not
limited to, a drug as defined in the Sherman Food, Drug and
Cosmetic Law or the Federal Food, Drug, and Cosmetic Act.
Excludes for the definition of "pharmaceutical" any
pharmaceutical that is regulated pursuant to the federal
Resource Conservation and Recovery Act (RCRA) of 1976, which
governs the management of solid and hazardous wastes, or the
Radiation Control Law. (HSC � 117747)
6) Defines "pharmaceutical waste" as any pharmaceutical that for
any reason may no longer be sold or dispensed for use as a
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drug, and excludes from this definition those pharmaceuticals
that still have potential value to the generator because they
are being returned to a reverse distributor for possible
manufacturer credit. (HSC � 117748)
7) Specifies that waste comprised only of pharmaceuticals is
biohazardous, and is considered "medical waste." (HSC �
117635)
8) Requires all medical waste be transported to an offsite
medical waste treatment facility to be transported by a
registered hazardous waste transporter. (HSC � 118000)
9) Establishes a voluntary drug repository and distribution
program for the purpose of distributing surplus medications
to persons in need of financial assistance to ensure access
to necessary pharmaceutical therapies. (HSC � 150200 et
seq.)
Pursuant to the Public Resources Code (PRC):
1) Requires pharmaceutical manufacturers that sell or distribute
a medication in California that is self-injected at home
through the use of a hypodermic needle, pen needle,
intravenous needle, or any other similar device to submit to
CalRecycle a plan that describes what actions, if any, the
manufacturer supports for the safe management of sharps
waste.
(PRC � 47115)
FISCAL EFFECT : Unknown.
COMMENTS :
Need for the bill : According to the author, "California is
experiencing an increasingly serious problem with prescription
drug abuse, accidental poisonings, and the detection of
pharmaceutical products in state waters. Local governments have
struggled to establish safe and convenient medication take-back
programs for the unused and expired prescription drugs, over the
counter drugs, and veterinary drugs found in our homes. Unused
medications are often flushed or thrown in the trash because
there are few, if any, safe and convenient options? Now that
CalRecycle's Model Guidelines have expired, there are no
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standards in place for how local entities should properly run
their voluntary take-back programs to ensure that collection and
disposal is safe, convenient, and secure. Due to the
prescription drug abuse epidemic in the state, guidelines for
collection to prevent further diversion are critical to
protecting public health-they can help by providing local
entities with a model for removing unwanted drugs from homes and
ensuring they are not resold or available to be abused after
consolidation at collection locations."
Impacts of improper disposal of pharmaceuticals : CalRecycle
asserts that pharmaceutical wastes are a societal problem
because they show up in the environment, particularly in our
waterways, and because some are "controlled substances" that can
be illegally diverted and abused. A U.S. Geological Survey
study conducted in 2002 found that 80 percent of streams sampled
in 30 states had measurable concentrations of prescription and
nonprescription drugs, steroids, and reproductive hormones.
Studies show that exposure even to low levels of pharmaceuticals
has negative effects on fish and other aquatic species and may
negatively affect human health. CalRecycle notes that
accidental prescription overdoses, teen and adult abuse of
prescription drugs, and impacts to surface waters and
groundwater when drugs are flushed down the toilet, all
highlight the need for safe pharmaceutical waste collection
programs.
The model HGPW collection and disposal program : Senate Bill 966
(Simitian, Chapter 542, Statutes of 2007) requires the
California Integrated Waste Management Board (CIWMB), which is
the predecessor to CalRecycle, to develop model programs for the
collection from consumers and proper disposal of unused or
expired home-generated pharmaceuticals. The CIWMB was also
required, when developing model programs, to evaluate programs
used by other state, local, and governmental entities, which it
did by survey. CalRecycle reports that it developed the
"Criteria and Procedures for Model Home-Generated Pharmaceutical
Waste Collection and Disposal Programs," which was adopted in
2010, based on the survey results and in consultation with the
Pharmaceutical Working Group, which included staff from CIWMB,
DPH, Board of Pharmacy, DTSC, and the State Water Resources
Control Board. The model program was meant to assist
organizations and local governments in creating programs through
which the public may return unused or expired HGPW, as well as
to meet the minimum criteria and goals delineated in SB 966.
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SB 966 required, at a minimum, the model programs to include:
1)A means by which a participant is required to provide, at no
additional cost to the consumer, for the safe take back and
proper disposal of drugs;
2)A means by which a participant is required to ensure the
protection of public health and safety, the environment, and
the health and safety of consumers and employees;
3)A means by which a participant is required to report on the
program for safety, efficiency, effectiveness, and funding
sustainability;
4)A means by which a participant shall protect against the
potential for the diversion of drug waste for unlawful use or
sale; and,
5)Providing notice and informational materials for consumers
about the potential impacts of improper disposal of drug waste
and the return opportunities for the proper disposal of drug
waste.
The regulatory requirements in SB 1014 are based upon the
minimum requirements for HGPW model programs as required by SB
966.
CalRecyle's HGPW report and recommendations : SB 966 also
required CalRecycle to prepare a report for the Legislature that
evaluated California's pharmaceutical waste collection programs
and provided recommendations to the Legislature for the
potential implementation of a statewide program and statutory
changes. CalRecycle submitted Report to the Legislature:
Recommendations for Home-Generated Pharmaceutical Collection
Programs in California, in December 2010, in which it
recommended that the Legislature adopt a combination of two
options related to pharmaceutical waste collection programs: 1)
statutory changes to establish clear state roles and
responsibilities, provide direction to resolve several
implementation challenges, and direct that the "Criteria and
Procedures for Model Home-Generated Pharmaceutical Waste
Collection and Disposal Programs" be refined and converted into
regulations; and 2) statutory direction to address funding
barriers by providing financing through a private sector
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approach with government oversight, commonly referred to as
product stewardship.
SB 1014 is consistent with the first recommendation in the
report, which suggests that the "Criteria and Procedures for
Model Home-Generated Pharmaceutical Waste Collection and
Disposal Programs" be refined and converted into regulations.
Have the model guidelines been effective ? While the statute
that required the HGPW model guidelines became inoperative on
January 1, 2013, entities can currently continue to follow the
guidelines. CalRecycle's 2010 report states that, based on
available information at the time, collection programs in
California gathered approximately 200,000 pounds of HGPW per
year. CalRecyle notes that these collection programs appear to
be quite safe with very low illegal diversion. Out of 256
collection sites, which represents 86 percent of all known
programs operating in California, a CalRecycle survey found that
in the previous 15 years there were no reported signs of illegal
drug diversion. CalRecyles asserts, however, that these
programs likely collect a small percentage of all home-generated
pharmaceutical waste. Of the approximately 61,000 pharmacies in
California, the number of pharmaceutical collection programs was
around 300 in 2010, with no large chain pharmacies participating
in the program. Only about one-third of the programs met the
voluntary model guidelines.
A 2014 CalRecycle report to the California State Senate
suggested that program participants face a number of challenges
that have limited program participation. These challenges
include: 1) local governments fund more than 80% of all
programs; 2) stakeholders consider the costs to be too high; 3)
under statute, HGPW is solid waste, but per DPH policy, it is a
medical waste when consolidated, therefore participation
requires compliance with tracking standards, medical waste
hauling standards, and disposal standards; and, 4) the
regulatory requirements, policies, and authority are too complex
(HGPW regulators and governmental stakeholders include: DPH,
Board of Pharmacy, DTSC, the State Water Resources Control
Board, the U.S. Drug Enforcement Administration, etc.). Should
this bill be enacted, the regulations required by this bill will
need to address some of these challenges in order for the HGPW
take-back program to be effective.
Two different regulatory systems : SB 1014 clarifies that HGPW,
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even if it is consolidated, is excluded from the definition of
medical waste if it is being handled by a collection and
disposal program operating in accordance with the regulations
required in the bill. DPH policy will likely still consider
HGPW that is not part of the program set up in the bill to be
medical waste when consolidated. Should this bill be enacted,
two different management systems for HGPW could exist, as some
will be considered medical waste, and some HGPW.
Double referral : This bill is double referred to the Assembly
Business and Professions Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
Alameda County Board of Supervisors (co-sponsor)
California Product Stewardship Council (co-sponsor)
California Alliance for Retired Americans (co-sponsor)
Clean Water Action (co-sponsor)
California Association of Sanitation Agencies
Californians Against Waste
Californians for a Healthy & Green Economy
California Resource Recovery Association
California State Board of Pharmacy
California State Sheriff's Association
Center for Environmental Health
City of Camarillo
City of Chula Vista
City of Roseville
City of Thousand Oaks
City of Torrance
County of Santa Clara
County Sanitation Districts of Los Angeles County
East Bay Municipal Utility District
El Dorado Irrigation District
Health Officers Association of California
League of Women Voters of California
Los Angeles County Board of Supervisors
Marin Sanitary Service
Natural Resources Defense Council
Pajaro Valley Community Health Trust
Sacramento State Student Health Services Pharmacy
San Francisco Bay Area Physicians for Social Responsibility
San Mateo County Board of Supervisors
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Santa Cruz County Board of Supervisors
Scan Davison
Worksafe
Opposition
One individual.
Analysis Prepared by : Shannon McKinney / E.S. & T.M. / (916)
319-3965